FDA - 電子書籍 1

E6 Good Clinical Practice  Guidance for Industry Part 11, Electronic Records; Electronic Signatures ー Scope and Application  CFR 21-- General Part 11, Electronic Records; Electronic Signa……続きを見る

Good Clinical Practice For Your Reference - Book 4  ICH - Clinical Safety E1 - E2F  ICH-E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for……続きを見る

PART 600 BIOLOGICAL PRODUCTS: GENERAL  PART 601 LICENSING  PART 606 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS  PART 607 ESTABLISHMENT REGISTRATION AND PRODUCT……続きを見る

In this ebook you will find the following guidance documents: ICH Q8 Pharmaceutical Development ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System続きを見る

Kemp Hastings and his investigative colleague Doctor Darlene Gammay are pursued by the Grand Lodge of Cairo (GLOC) who are hellbent on murdering Darlene now that she has been given a glimpse into th……続きを見る

Financial Conflict Of Interest Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) Responsible Prospective Contractors (……続きを見る

Guidance for Industry Oversight of Clinical Investigations ー A Risk-Based Approach to Monitoring 続きを見る

ICH - Safety Guidelines S1A – S9  S1A Guideline on the Need for Carcinogenicity Studies  S1B Testing for Carcinogenicity of Pharmaceuticals  S1C(R2) Dose Selection for Carcinogenic……続きを見る

Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No ne……続きを見る

Good Clinical Practice For Your Reference - Book 5  ICH - Efficacy Guidelines E3 – E15  ICH-E3: Clinical Study Reports ICH-E3 - Structure and Content of Clinical Study Reports  ICH-……続きを見る

Regulations on: Drug Labeling, Drug Advertising, Drug Marketing, Drug Imprinting, Drug Names, Promotional Materials PART 99 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BI……続きを見る

The year is 1127 and the Knights Templar in the Holy Land have discovered the riches of King Solomon, King David & Christendom. A single Templar Vessel named the Temple Unicorn is despatched from Du……続きを見る

An adult Tabletop RPG where you can roleplay being a sex demon. Your purpose is to drag souls to hell, and you get to do it in the most pleasurable way. Find the perfect human of your choice, use yo……続きを見る

Strategies for targeted individuals is a short ebook with brief description of being a TI, solutions for defense and shielding from mind control technologies and ways to cope as a TI to survive in a……続きを見る

Harvard University Professor David C. McClelland is chiefly known for his work on achievement motivation, but his research interests extended to personality and consciousness. He pioneered workplace……続きを見る

This textbook offers an introductory overview of eight hotly-debated topics in second language acquisition research. It offers a glimpse of how SLA researchers have tried to answer common questions ……続きを見る

What if you could be the designer of your life? What if you could get on a boat and go on an adventure called ‘you’ and you don’t have to know what that looks like? What if being a leader begins wit……続きを見る

The third edition of New Paths To Side Businesses is the revised and edited version. The unique perspective with more innovative ideas to incorporate strategies in marketing, business, entrepreneurs……続きを見る

“Introducing DEEP Clearing” tells about a new self-development modality. DEEP builds on the age-old model of head, heart and body: we have a mental, an emotional, and a physical side. Emotional char……続きを見る

Neurological weapons & Psychological solutions is the free and short revised version of Decoding The Matrix. The condensed version is describing the psychological effects from the neuroweapons, whic……続きを見る

Java continues to grow and evolve, and this cookbook continues to evolve in tandem. With this guide, you’ll get up to speed right away with hundreds of hands-on recipes across a broad range of Java ……続きを見る

The advent of the Wall Heidi's thirteenth birthday is coming up, but she's disappointed -- her mother is pregnant and refuses to make the annual summer visit to Heidi's grandmother. What's more, it'……続きを見る

This briskly told history of Reformed Protestantism takes these churches through their entire 500-year historyーfrom sixteenth-century Zurich and Geneva to modern locations as far flung as Seoul and……続きを見る

Mobile Learning Communities explores the diverse ways in which traveling groups experience learning ‘on the run’. This book provides empirical evidence that draws on the authors’ 17 years of continu……続きを見る

In this volume, originally published in 1903, is a practical account of Mr. Dales experiences of the hunting fields of Leicestershire and the surrounding countries. It will still appeal to those wit……続きを見る

This edition of Against the Pelagians comes complete with a Touch-or-Click Table of Contents, divided by each book. St. Jerome (formerly Saint Hierom) was a Roman Christian priest, confessor, theolo……続きを見る

Today we are seeing a new form of blended learning: not only is technology enhancing the learning environment but formal and informal learning are combining and there is self- and peer-assessment of……続きを見る

What it was like to be as rich as Rockefeller: How a house gave shape and meaning to three generations of an iconic American family One hundred years ago America's richest man established a dynastic……続きを見る

Alternatively titled - "Recollections of twenty-one years passed in Java,Singapore, Australia and China", published in London in 1846, was written by the author G.F. Davidson of Hull, Eng……続きを見る

This is not your grandmother's fairy tale. A fantasy novel that turns the genre on its head, "The Seeds" follows Trooper Angus Mayweather as he is thrust into the conflict faced by twin sisters Dart……続きを見る